Expandable surgical heart valve indicators
A prosthetic heart valve configured to replace a native heart valve and for post-implant expansion and having a valve-type indicator thereon visible from outside the body post-implant. The indicator communicates information about the valve, such as the size or orifice diameter of the valve, and/or that the valve has the capacity for post-implant expansion. The indicator can be an alphanumeric symbol or other symbol or combination of symbols that represent information about the characteristics of the valve such as the valve size. The capacity for post-implant expansion facilitates a valve-in-valve procedure, where the valve-type indicator conveys information to the surgeon about whether the implanted valve is suitable for the procedure and informs the choice of the secondary valve.
1 . A surgical prosthetic heart valve configured for open heart surgical implantation having a labeled valve size selected from a range, in 2 mm increments, between 19 and 33 mm, comprising:
a support frame defining a flow orifice therethrough, and the flow orifice has a diameter equal to the labeled valve size, the support frame defining a dimensionally stable circumferential base modified to permit a limited amount of post-implant expansion when subjected to radial outward forces from within;
a peripheral sewing ring around the circumferential base formed of suture-permeable material and configured for anchoring the valve to a native annulus using sutures;
a plurality of leaflets ensuring one-way flow through the flow orifice; and
a valve-size indicator on the support frame indicating the labeled valve size, and a valve-type indicator on the support frame that signifies the capability of the support frame for post-implant expansion.
2 . The heart valve of claim 1 , wherein the support frame defines a plurality of cusps that curve toward an inflow end of the valve separated by commissures that project toward an outflow end of the valve, each of the leaflets attaching at a peripheral edge along the cusps and commissures of the support frame.
3 . The heart valve of claim 2 , wherein the support frame comprises a tubular band with a diameter that is expandable post-implant, and the valve-size indicator is located on the tubular band.
4 . The heart valve of claim 3 , wherein there are a plurality of valve-size indicators each aligned with a commissure of the support frame.
5 . The heart valve of claim 1 , wherein the valve-size indicator comprises a numerical value that equals the labeled valve size in millimeters.
6 . The heart valve of claim 1 , wherein the valve-size indicator comprises a non-numeric symbol.
7 . The heart valve of claim 3 , wherein the tubular band shows up as a positive image on an external imager, and the valve-size indicators are each formed by one or more voids integrated into the tubular band which show up as negative images on the external imager.
8 . The heart valve of claim 1 , wherein the support frame comprises a structural component that shows up as a positive image on an external imager, and the valve-size indicator is formed by one or more voids integrated into the structural component which show up as negative images on the external imager.
9 . The heart valve of claim 1 , wherein there are a plurality of valve-size indicators distributed around the support frame and each comprises a numerical value.
10 . The heart valve of claim 1 , wherein there are a plurality of valve-size indicators distributed around the support frame and each comprises a non-numeric symbol.
11 . A surgical prosthetic heart valve configured for open heart surgical implantation having a labeled valve size selected from a range, in 2 mm increments, between 19 and 33 mm, comprising:
an expandable support frame defining a flow orifice therethrough, and the flow orifice has a diameter equal to the labeled valve size, the support frame defining a dimensionally stable circumferential base adapted to permit a limited amount of post-implant expansion when subjected to radial outward forces from within;
a peripheral sewing ring around the circumferential base formed of suture-permeable material and configured for anchoring the valve to a native annulus using sutures;
a plurality of leaflets ensuring one-way flow through the flow orifice; and
a valve-type indicator on the support frame that signifies the capability of the support frame for post-implant expansion.
12 . The heart valve of claim 11 , wherein the prosthetic heart valve also has a valve-size indicator indicating the labeled valve size.
13 . The heart valve of claim 11 , wherein the support frame defines a plurality of cusps that curve toward an inflow end of the valve separated by commissures that project toward an outflow end of the valve, each of the leaflets attaching at a peripheral edge along the cusps and commissures of the support frame.
14 . The heart valve of claim 13 , wherein the support frame comprises a tubular band with a diameter that is expandable post-implant, and the valve-type indicator is located on the tubular band.
15 . The heart valve of claim 14 , wherein there are a plurality of valve-type indicators each aligned with a commissure of the support frame.
16 . The heart valve of claim 12 , wherein the valve-size indicators each comprise a numerical value that equals the labeled valve size in millimeters.
17 . The heart valve of claim 15 , wherein the tubular band shows up as a positive image on an external imager, and the valve-type indicators are each formed by one or more voids integrated into the tubular band which show up as negative images on the external imager.
18 . The heart valve of claim 11 , wherein the support frame comprises a structural component that shows up as a positive image on the external imager, and the valve-type indicator is formed by one or more voids integrated into the structural component which show up as negative images on the external imager.
19 . The heart valve of claim 11 , wherein there are also a plurality of valve-size indicators distributed around the support frame and each comprises a numerical value that equals the labeled valve size in millimeters.
20 . The heart valve of claim 11 , wherein there are also a plurality of valve-size indicators distributed around the support frame and each comprises a non-numeric symbol.
21 . The heart valve of claim 11 , wherein the support frame comprises a tubular band, and the valve-type indicator is formed in the tubular band and selected from the group consisting of a series of holes, a concavity and a slot.
22 . The heart valve of claim 12 , wherein the valve-size indicator is formed by strips of radiopaque material incorporated into the sewing ring.
23 . The heart valve of claim 1 , wherein the support frame comprises a tubular band, and the valve-type indicator is formed in the tubular band and selected from the group consisting of a series of holes, a concavity and a slot.